510(k) · Cleared
Recalled · Class II · 2017Myelotec Video Guided Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myelotec, Inc. · HRX Arthroscope
Cleared on Aug 11, 1998 as substantially equivalent to K954584 (Medic Evaluation Devices & Instruments Corp., 1996) after a 167-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 11, 1998
- Review
- 167 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954584 (1996). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954584 Racz Epidural CatheterMedic Evaluation Devices & Instruments Corp. · 1996 · Recalled
- This deviceK980734 Myelotec Video Guided CatheterMyelotec, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK150789 Spinaut-E, Spinaut-IImedicom Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK241410 EDEN ControlCathJmt Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK201113 Resascope RS-01/BAdvanced Medical Systems Group Srl · 2020
- Descendant · cites it directly · 0 of its ownK151268 Spinaut-V, Spinaut-S, Spinaut-IImedicom Co., Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K150789Spinaut-E, Spinaut-IImedicom Co., Ltd. · 2016 · cites it directly1descendant
- K241410EDEN ControlCathJmt Co., Ltd. · 2025 · 2 generations on0descendants
- K201113Resascope RS-01/BAdvanced Medical Systems Group Srl · 2020 · cites it directly0descendants
- K151268Spinaut-V, Spinaut-S, Spinaut-IImedicom Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954584 | Racz Epidural Catheter | Medic Evaluation Devices & Instruments Corp. | 1996 | 1 |
| 0 (this device) | K980734 | Myelotec Video Guided Catheter | Myelotec, Inc. | 1998 | — |
| +1 | K150789 | Spinaut-E, Spinaut-I | Imedicom Co., Ltd. | 2016 | — |
| +2 | K241410 | EDEN ControlCath | Jmt Co., Ltd. | 2025 | — |
| +1 | K201113 | Resascope RS-01/B | Advanced Medical Systems Group Srl | 2020 | — |
| +1 | K151268 | Spinaut-V, Spinaut-S, Spinaut-I | Imedicom Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954584 | Racz Epidural CatheterSummary page 1…: ANESTESIOLOGY CLASSIFICATION NAME: CATHETER, CONDUCTION, ANESTHESIA PRODUCT CODE: 73BSO . REGULATION NUMBER: 868.5120 PREDICATE DEVICE: RACZ Tun-L-Kath 510(k) number - K954584 DESCRIPTION AND INTENDED USES: The MYELOTEC VIDEO GUIDED CATHETER (VGC) consists of a flexible double lumen catheter, steering… | 1996 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 2, 2017 | Class II | Z-2779-2017 | Device Design | Obstructed/blocked port from defective VGC Access Port Body component. |
| Dec 19, 2007 | Not classified | Z-0587-2008 | Error in labeling | Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
when used with a fiberoptic endoscope, this device can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980734: Myelotec Video Guided Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980734
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026